(135 days)
The Akesis Galaxy RTi Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures for adults.
The Akesis Galaxy RTi, is a medical teletherapy device, which contains (30) Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimators and a blocking position. consists of a) The y-ray treatment unit, and b) interface to a stereotactic localization system, and c) kV x-ray positioning and verification system
The provided text describes a medical device, the Akesis Galaxy RTi Rotating Gamma System, which is a radionuclide radiation therapy system intended for stereotactic irradiation of human head structures in adults. The submission is a 510(k) premarket notification, indicating the device is being compared to a legally marketed predicate device (Akesis Galaxy RTx Rotating Gamma System).
Based on the provided information, the study focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria in the context of diagnostic accuracy (e.g., sensitivity, specificity) derived from a clinical study with a test set, ground truth, and expert readers.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific acceptance criteria in the form of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the device's clinical application. Instead, acceptance criteria are aligned with demonstrating substantial equivalence to a predicate device and complying with recognized standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | "The Akesis Galaxy RTi has the same intended use... as the predicate device." |
| Operating Principle | "uses the same radioisotope, applies the same operating principle... as the predicate device." |
| Technical Characteristics | "has the same technical characteristics... as the predicate device." (Acknowledged differences: Addition of a kV x-ray imaging system, interface to compatible immobilization devices). |
| Performance Specifications | "meets the same performance specifications as the predicate device." Performance tests demonstrated that the Akesis Galaxy RTi "has met its specifications, demonstrated substantially equivalent performance to the predicate device and is suitable for its intended use." |
| Regulations and Standards | "Both the predicate and the Akesis Galaxy meet the same set of regulations and standards." Specifically, "The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC. Successful testing was performed in accordance with IEC standards 60601-1-3, 60601-1-6, 60601-2-68, 60601-2-11, 60601-1-2, 61217, 62274 and 62366." |
| Electrical Safety and EMC | "Electrical safety and electromagnetic compatibility (EMC) testing was conducted on this medical device. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC. Successful testing was performed in accordance with IEC standards 60601-1-3, 60601-1-6, 60601-2-68, 60601-2-11, 60601-1-2, 61217, 62274 and 62366." |
| Hardware/Software V&V | "Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices." The software for this device was considered as a "major" level of concern." |
| Biocompatibility | "Biocompatibility testing was not performed since this device does not have any direct tissue contacting components / parts. This is in accordance with the Guidance for Industry and FDA Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", September 2020." |
| Safety and Effectiveness Issues | "Use of the Akesis Galaxy RTi does not raise any new or different issues of safety or effectiveness when compared with the predicate device." |
Regarding the Absence of Diagnostic Performance Studies for AI/Machine Learning Devices:
It is crucial to note that this 510(k) submission is for a radionuclide radiation therapy system, which is a physical device used for treatment. It is not an AI/machine learning diagnostic device where performance is typically measured in terms of sensitivity, specificity, or AUC against a ground truth established by experts. Therefore, many of the questions regarding sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this type of device and submission.
The "study that proves the device meets the acceptance criteria" in this context refers to engineering tests, verification and validation activities, and comparisons of technical characteristics to a predicate device, rather than a clinical trial assessing a diagnostic AI algorithm.
Here's a breakdown for the N/A questions:
2. Sample size used for the test set and the data provenance: N/A (Not an AI/diagnostic device clinical study). The performance data cited are related to engineering and safety standards compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth as understood in AI/diagnostic performance studies is not applicable here).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this device does not involve human readers interpreting images with or without AI assistance for diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a therapeutic device, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" here is compliance with engineering standards and specifications, not clinical diagnostic accuracy.
8. The sample size for the training set: N/A. (Not an AI/machine learning algorithm).
9. How the ground truth for the training set was established: N/A.
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March 5, 2021
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Akesis Inc % Mr. Christopher Brown Director Quality Assurance and Regulatory Affairs 5129 Commercial Circle CONCORD CA 94520
Re: K203146
Trade/Device Name: Akesis Galaxy RTi Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: Class II Product Code: IWB Dated: January 28, 2021 Received: January 29, 2021
Dear Mr. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203146
Device Name Akesis Galaxy RTi
Indications for Use (Describe)
The Akesis Galaxy RTi Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures for adults.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Premarket Notification [510(k)] Summary Akesis Galaxy Rotating Gamma System
The following information is provided following the format of 21 CFR 807.92.
I. GENERAL INFORMATION
| Submitter's Name: | Akesis Inc.5129 Commercial CircleConcord, CA 94520 |
|---|---|
| Contact Name: | Christopher BrownPhone: +1 925 408 1381Fax: +1 925 326 2646 |
| Date Prepared: | October 19, 2020 |
| II. DEVICE INFORMATION | |
| Proprietary Name: | Akesis Galaxy RTi |
| Classification Name: | Radionuclide radiation therapy system |
| Device Classification: | 21 CFR 892.5750 |
| Device Class: | Class II |
| Product Code: | IWB |
| Common/Usual Name: | Radionuclide radiation therapy system |
| III. PREDICATE DEVICE | Akesis Galaxy RTx Rotating Gamma System (K200050) |
| IV. DEVICE DESCRIPTION | The Akesis Galaxy RTi, is a medical teletherapy device, which contains(30) Cobalt-60 sources, distributed in a single, compact source carrier orsource drawer, which is inside a hemispheric shield. Immediately adjacentto the source unit is the "built-in" primary collimator. An independentlyrotating secondary collimator hemisphere contains 4 sizes of collimatorsand a blocking position. |
| consists of a) The y-ray treatment unit, and b) interface to a stereotacticlocalization system, and c) kV x-ray positioning and verification system | |
| V. INTENDED USE | The Akesis Galaxy RTi Rotating Gamma System, is a teletherapy deviceintended for the stereotactic irradiation of human head structures in adults |
| VI. INDICATIONS FOR USE | The Akesis Galaxy RTi Rotating Gamma System, is a teletherapy deviceintended for the stereotactic irradiation of human head structures in adults |
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VII. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Akesis Galaxy RTi has the same intended use, uses the same radioisotope, applies the same operating principle, has the same technical characteristics and meets the same performance specifications. Both the predicate and the Akesis Galaxy meet the same set of regulations and standards.
The following technological differences exists between the subject and the predicate device:
- -Addition of a kV x-ray imaging system
- Provides an interface to compatible immobilization devices -
VIII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence:
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and electromagnetic compatibility (EMC) testing was conducted on this medical device. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC. Successful testing was performed in accordance with IEC standards 60601-1-3, 60601-1-6, 60601-2-68, 60601-2-11, 60601-1-2, 61217, 62274 and 62366.
Hardware and Software Verification and Validation Testing
Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices." The software for this device was considered as a "major" level of concern.
Biocompatibility Testing
Biocompatibility testing was not performed since this device does not have any direct tissue contacting components / parts.
This is in accordance with the Guidance for Industry and FDA Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", September 2020.
Animal and Clinical Studies
Animal and clinical testing was not required.
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Summarv
These tests have demonstrated that the Akesis Galaxy RTi has met its specifications, demonstrated substantially equivalent performance to the predicate device and is suitable for its intended use.
IX. CONCLUSIONS
The Akesis Galaxy RTi has the same intended use, fundamental scientific technology and principles of operation as the predicate device.
Use of the Akesis Galaxy RTi does not raise any new or different issues of safety or effectiveness when compared with the predicate device.
Performance tests have demonstrated that the Akesis Galaxy RTi has met its specifications, demonstrated substantially equivalent performance to the predicate device and is suitable for its intended use.
§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.